Presentation (CTI)

OBJECTIVES: As the vaccine market grows increasingly competitive, manufacturers must employ strategic approaches to sustain relevance. This research explores how vaccines maintain competitiveness over time by analysing trends among FDA-approved products in disease areas with three or more licensed vaccines.
METHODS: We conducted a structured review of the FDA-approved vaccine database, focusing on disease areas where at least three vaccines have been approved in the past 20 years. For each disease area, we analysed how individual vaccines evolved after approval to maintain relevance in a competitive landscape. This included evaluating a range of differentiating attributes, such as antigen coverage, clinical efficacy, formulation, dosing schedule, and delivery route, among others. From the observed patterns across disease areas, we developed a framework of strategic archetypes that manufacturers commonly use to sustain or enhance market position over time.
RESULTS: To stay competitive, vaccines must show clinical, coverage, or logistical improvements. Four key strategic archetypes emerged from vaccine launches in the past 20 years: 1. Strain/Antigen Expansion: Adding new variants or serotypes to broaden protection and differentiate from competitors. 2. Clinical Differentiation: Demonstrating superior efficacy, safety, or offering more patient-friendly platforms to drive uptake. 3. Formulation Innovation: Enhancing stability, delivery method, or dosing schedules to improve convenience and adoption. 4. Population Evolution: Expanding indications to new age groups, risk profiles, or underserved niches with high unmet need. These strategies are often used in combination. Their success depends on factors like timing, competitive landscape, and the robustness of supporting evidence. Vaccines that continually adapt while maintaining scientific and regulatory integrity are more likely to thrive in competitive spaces.
CONCLUSIONS: Long-term vaccine competitiveness relies on strategic evolution across clinical, regulatory, and policy dimensions. Understanding and applying these archetypes can inform development and access strategies, especially in crowded or rapidly evolving disease areas.